As hearings on Capitol Hill these past two months (and in the months to come) have examined the issue of pharmaceutical pricing to inform potential legislation as well as to garner attention, FDA has been addressing the issue in the only way the agency can, through policies that enhance the development of generic and biosimilar competition for brand name drugs. In fact, in 2017, FDA approved a record number of generics – 1000 – a record the agency broke in 2018. Overall, the effort at promoting the development of generics as a means of addressing price has not only been assiduous, but wide in scope.
For starters, on Friday, February 22, the agency announced that it was releasing 74 product-specific guidance documents, 49 covering complex drugs, including 16 for which there are no approved generics with the aim of supporting approaches to developing new generics. It is one of many examples of how FDA has sought to move the needle in the generics market place. This is at least in accordance with a statement from the commissioner made after a GAO report released in early 2018 recommended that FDA revise its guidance documents on complex drugs.
Much of the activity is related to the fact that in May of 2017, FDA announced its Drug Competition Action Plan. Almost immediately thereafter (in June) published a list of off-patent, off-exclusivity brand name drugs that did not have competition as well as implementing a policy to help expedite review of generic applications. In that same announcement the Commissioner stated that FDA would expedite the application for a generic drug until there were three generics available for a brand product. In July of that same year, the agency held a hearing to identify where there were ways for the agency to enhance generic development.
In between the announcement of the Drug Competition Action Plan and the product-specific guidances, there was a good deal of other action announced or taken by the agency:
- Policy Change – On the occasion of the release of the Trump Administration’s blueprint for addressing drug pricing, FDA issued a Statement from the Commissioner in which he reiterated the agency’s commitment to making an impact in the process for approving generics and in calling out “gaming” practices that might delay competitive generics in market entry and a few days later announced that the agency would be publishing a list of companies. In January of this year, the Commissioner issued a statement to signal the coming issuance of new policies to support generic entry into the market for complex drugs;
- Funding to Facilitate Generics – On February 13 of last year, FDA sought additional funding to, among other things, modernize generic drug review from text-based to data-based assessment. And in July announced the formation of a work group to examine a policy framework to look at importation of drugs address situations where there is only one U.S. approved and marketed version of an older drug that may not be commonly used, but is medically important and often involving generic medicines.
- Gaming Practices – Last Spring, the Commissioner announced steps on one of the issues touched upon in this week’s Senate Finance Committee Hearing on drug pricing – the “gaming” of the system to delay generic competition. The agency began publishing a list of companies identified as potentially blocking access to samples of branded products. That same month – also in a Statement from the Commissioner – FDA announced new policies to reduce the ability of brand drug makers to use REMS programs as a means to blog generic market entry. In October the agency announced new options to further curb “gaming” of the process by revising a draft guidance regarding the use of citizen petitions to add a resource burden to generic review process.
- Expedited Approval Pathways – In August the agency announced the first generic approval under the Competitive Generic Therapy designation – a new approval pathway created to expedite the development of new entries into the market where there is a lack of competition, formalized in an announcement this month and defined as a pathway granted to a company submitting an application where there is not more than one approved drug in the Orange Book. In October of last year in a Statement from the Commissioner new guidance documents were issued to advance the development of generic transdermal and topical delivery systems with the aim of enhancing the development of generic versions of complex drugs.
- Safety – This month, in the wake of media reports regarding the questionable quality of some imported generics, the Commissioner and the head of CDER announced steps regarding the oversight of safety and quality issues related to both domestic and imported products
As an agency, FDA has a narrow band-width in which to operate when it comes to the drug pricing issue. But within the space it has, the agency has been very active and very comprehensive. In fact, if you look for the word “generic” in the headlines of agency press releases between 2013 and 2017, you will find almost nothing. If you look at it in the past few years there are at least a dozen. If not activist, the agency has certainly been active.